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Defibtech DDU-100
Semi-Automatic External
Defibrillator
User Manual Addendum
Changes to Chapter 4 (Using the DDU-100
AED) of the Defibtech User Manual have been
made to reflect the latest version of Defibtech
software (V2.0). Chapter 4 has been reprinted
in this Addendum with changes marked in grey.
Please keep this Addendum with your User
Manual.
DAC-510E (I-02) Rev. B
Notices
Defibtech shall not be liable for errors contained herein or for incidental or
consequential damages in connection with the furnishing, performance, or use
of this material.
Information in this document is subject to change without notice. Names and
data used in the examples are fictitious unless otherwise noted.
Limited Warranty
The information in the Defibtech AED User Manual does not constitute any
warranty as to the Defibtech AED or any related products. The “Limited
Warranty” shipped with Defibtech AED products serves as the sole and
exclusive warranty provided by Defibtech L.L.C. with respect to these products.
Copyright
Copyright 2001-2006 Defibtech, L.L.C.
All rights reserved. No part of this documentation may be reproduced or
transmitted in any form by any means without the express written consent of
Defibtech, L.L.C.

CAUTION :
Federal law (USA) restricts this device to
sale by or on the order of a physician
DAC-510E (I-02) Rev. B
Contents
4
Using the DDU-100 AED................................................................ 1
4.1
4.2
4.3
4.4
Overview....................................................................................1
Checking DDU-100 AED Status.....................................................2
Turning on the DDU-100 AED........................................................2
Preparation..................................................................................3
4.4.1
4.4.2
4.4.3
4.4.4
4.4.5
4.4.6
Call for Help............................................................................... 3
Preparing the Patient................................................................... 3
Opening the Pad Package............................................................. 3
Connecting Defibrillation Pads to the DDU-100 AED........................ 3
Applying Pads to the Patient......................................................... 4
Follow DDU-100 AED Prompts..................................................... 5
4.5 Heart Rhythm Analysis..................................................................6
4.6 Delivering the Shock.....................................................................7
4.7 No Shock Required.......................................................................8
4.8 Post-Shock CPR...........................................................................9
4.9 Post Use Procedures...................................................................10
4.10Operational Environment.............................................................10
10 Contacts....................................................................................... 11
DAC-510E (I-02) Rev. B
DAC-510E (I-02) Rev. B
4 Using the DDU-100 AED
This chapter describes how to use the DDU-100 AED. The DDU-100 AED was
designed for simple operation, allowing the operator to focus on the patient.
There are only two control buttons and four light emitting diode (LED) indicators.
Concise and easily understandable voice messages and prompts guide the
operator through the use of the unit.
The following sections describe in detail how to use the DDU-100 AED. The
basic steps for use are:
Turn the DDU-100 AED ON by pressing the ON/OFF button.
Connect pads to AED if not yet connected.
Place pads on patient (follow instructions on pad package).
Follow voice prompts.
Press SHOCK button if instructed by the AED.
4.1 Overview
Pad
Connector
Active Status
Indicator
ON/OFF
Button
check pads
Indicator
LEDs
do not touch patient
analyzing
Shock Button
Speaker
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4.2 Checking DDU-100 AED Status
Once a fully functional battery pack with a non-discharged 9V battery is installed
in the DDU-100 AED, an LED indicator located in the corner of the unit actively
indicates unit status. If unit is fully operational, the Active Status Indicator
(“ASI”) will blink green and if the unit needs attention, the ASI will blink red.
Anytime the ASI blinks red and a good 9V battery is installed, the unit will also
“beep” periodically to call attention to itself.
The indicator is powered by a replaceable 9V battery in the battery pack. If the
9V battery has discharged, active status indication will not be available. In this
case, the 9V battery should be immediately replaced to restore active status
indication. If only the 9V battery is depleted, the DDU-100 AED will still be fully
functional when turned on and can be used in the on-state normally.
• Off: Battery pack not installed, AED
is defective, or the 9V battery is
discharged. Install functional battery
pack or replace the 9V battery in the
battery pack.
Active
Status
Indicator
• Steady-On green: DDU-100 AED is ON
and operating normally.
• Blinking green: DDU-100 AED is OFF
and ready to operate normally.
• Blinking red: DDU-100 AED is OFF
and the AED or battery pack needs
attention.
• Steady-On red: DDU-100 AED is ON
and has detected an error.
4.3 Turning on the DDU-100 AED
Press the ON/OFF button to turn the DDU-100 AED on. The unit will emit
a “beep” and all the LEDs will light up temporarily. The ON/OFF button will
illuminate green anytime the AED is on. Voice prompts will guide the operator in
the use of the unit. To turn the unit off, press the button again. The Active Status
Indicator (“ASI”) will indicate the state of the unit.
• ASI off or blinking: The Device is OFF.
Press green ON/OFF button to turn the
device ON.
ON-OFF/
DISARM
• ASI on (green): The device is ON.
Press green ON/OFF button to turn
device OFF.
• ASI on (red): An error has been
detected and unit will turn off
automatically.
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4.4 Preparation
4.4.1 Call for Help
As soon as the AED is turned on the unit will prompt the user to “call for
help”. This indicates that the first step in a rescue should always be to contact
professional emergency services.
If another person is available, the user should direct that person to call for help
and then continue the rescue without delay.
4.4.2 Preparing the Patient
Prepare the patient by removing any clothing from the patient’s chest. Wipe
away moisture from the chest if necessary (the defibrillation pads will stick
better on dry skin). If necessary, shave excessive chest hair, which can prevent
effective patient-electrode contact. To ensure that electrode pads fully contact
the patient’s skin, check that no jewelry or other objects are directly underneath
where the pads will be placed.
4.4.3 Opening the Pad Package
Remove the pad package from the pad storage slot at the back of the AED.
Open the pad package by tearing along the dotted line, starting at the black arrow
(follow directions on the package). Pull the protective backing from the pads and
check that the pads are:
•
•
•
•
Free from obvious signs of damage
Clean of excessive debris (for example, dirt if the pad was dropped)
Not dried out, and that the gel is sticky and will adhere to the patient
Not expired. Do not use pads after the expiration date printed on the
package
If any of these conditions is found, use a new set of pads.
4.4.4 Connecting Defibrillation Pads to the DDU-100 AED
The DDU-100 AED is designed to be stored with the
defibrillation pad connector attached to the unit, while the pads
themselves remain sealed in their package. This reduces the
time needed to setup and start treatment in an emergency.
The Defibtech AED should be stored with the pad connector
plugged into the unit. However, if pads were damaged or not
properly connected, you may need to substitute a new set of
pads during an emergency. The pad connector is on the corner
of the AED.
To remove an old set of pads, pull firmly on the pad connector. Do not reuse
used pads. Insert the connector for the new pads as shown. The connector will
only fit in one way – if the connector does not fit, rotate the connector before
trying again. Insert connector firmly until it is completely seated in the unit.
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If not needed for immediate use, the pad package can then be stored in the
pad storage slot in the back of the DDU-100 AED. After connecting the pads
connector to the unit, push the pad package, with the pictures on the package
facing up and out, rounded end first, into the pad holder compartment on the
back of the AED. When the pad pack is fully inserted, press the pad cable into
the groove in the back of the unit to hold it in place and tuck any excess cable
behind the pad package.
4.4.5 Applying Pads to the Patient
Correct pad placement is essential for effective
analysis of the patient’s cardiac rhythm and
subsequent shock delivery (if required). Remove the
pads from the pad package by tearing the package
along the dotted line near the top of the package.
Remove the pads from the package and follow the
directions and diagram showing proper defibrillation
pad placement located on the defibrillation pad
package. Peel off the protective backing from each pad before placing it as
shown on the picture on the pad. Peel the backing off only when the pad is
ready to be placed. Place the pads with the sticky side of the pad on the
patient’s skin. Pad placement on infants or children under 8 years is different
than placement for adults or children older than 8 years. Place the pads as shown
in the diagram.
For adults and children 8 years or older
use adult pads: Place one pad just below
the patient’s right collar bone as shown in the
picture. Place the second pad over the ribs on
the patient’s left side below the left breast, also
as shown.
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For infants and children under 8 use
child/infant pads: Place one pad in the
center of chest and back, as shown.
4.4.6 Follow DDU-100 AED Prompts
At this point, the DDU-100 AED will check to make sure that the pads are well
connected to the patient and that an adequate ECG signal is being received. Do
not touch the patient, eliminate any patient movement, and cease CPR at this
time.
If there is a problem with the pad connection, connector connection, patient
motion or other interference, the AED will guide the operator with audible and
visual prompts. Visual prompts consisting of flashing LEDs with associated
labeling reinforce the audio prompts and aid in high ambient noise environments.
Pad related voice prompts:
“Plug in pads connector” – This indicates that the DDU-100 AED has
determined that the pads are not properly connected to the unit. Check that the
connector is fully inserted into the unit. If the prompts continue, try removing
and reinserting the pads connector or try a new set of pads. The “check pads”
LED will flash red during this message.
“Remove pads from package in back of unit” – This indicates that the user
should remove and tear open the pad package located in the back of the unit.
“Apply pads to patient’s bare chest as shown” – This indicates that the DDU100 AED has determined that the pads are not placed on the patient. Place
pads on the patient following instructions on the pad package. If the prompts
continue, try replacing the pads with a new set. The “check pads” LED will flash
red during this message.
“Plug in and apply pads” – This indicates that the DDU-100 AED has
determined that the pads are not plugged in and not applied to the patient.
Check that the connector is fully inserted into the unit. If the prompts continue,
try removing and reinserting the pads connector or try a new set of pads. The
“check pads” LED will flash red during this message.
“Poor pad contact to patient,” “Press pads firmly” – This indicates that the
pads are not making proper contact with the patient and that the impedance is
out of range for proper ECG analysis and shock delivery. Check that the pads are
properly placed and fully adhering to the patient and that there are no air bubbles
between the pads and the patient. Make sure that the pads are not touching
each other. If the pads are not sticking due to moisture, dry the patient. If the
pads are not sticking due to excessive hair, shave or clip excessive chest hair. If
the prompts continue, try replacing the pads with a new set. The “check pads”
LED will flash red during this message.
“Replace pads” – This indicates that the pads are not making proper contact
with the patient and that the impedance is out of range for proper ECG analysis
and shock delivery. If another set of pads is available, replace the pads,
otherwise check that the pads are properly placed and fully adhering to the
patient. Make sure that the pads are not touching each other. If the pads are
not sticking due to moisture, dry the patient. If the pads are not sticking due to
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excessive hair, shave or clip excessive chest hair. If the prompts continue, try
replacing the pads with a new set. The “check pads” LED will flash red during
this message.
“Check pads” – This indicates that the pads are making improper contact with the
patient or touching each other and that the impedance is out of range for proper ECG
analysis and shock delivery. Check that the pads are not touching each other and
that the patient is dry. If the prompts continue, try replacing the pads with a new
set. The “check pads” LED will flash red during this message.
“Pausing for CPR” – This indicates that the user should stop attempting to resolve
problems with the pads and assess the condition of the patient. The user will be
prompted to begin CPR, if needed, for a two-minute period.
Motion / Interference related voice prompts:
“Stop motion” – This indicates that the DDU-100 AED has detected motion in the
patient. Stop all patient motion, including CPR, in response to this message. If the
patient is being transported, stop the vehicle to stop the motion. The “do not touch
patient” LED will flash red during this message.
“Stop interference” – This indicates that the DDU-100 AED has detected
interference on the ECG signal. Eliminate any radio or electrical sources of
interference. Check the pads to make sure they are adhering properly to the patient.
If the environment is very dry, minimize movement around the patient to reduce
static discharges. The “do not touch patient” LED will flash red during this message.
“Pausing for CPR” – This indicates that the user should stop attempting to resolve
motion and/or interference problems and assess the condition of the patient. The
user will be prompted to begin CPR, if needed, for a two-minute period.
4.5 Heart Rhythm Analysis
Once the DDU-100 AED has determined that the pads are making a good
connection to the patient, the AED will start the ECG rhythm analysis. The unit
analyzes the ECG signal and determines whether a shockable or non-shockable
rhythm is present. While analyzing, the AED will continue to monitor the pad
connections and will abort analysis if it detects any pad problems. It will also
continue to monitor for excessive motion or interference and will abort analysis if
those conditions are detected.
Analysis related voice prompts:
“Analyzing heart rhythm” – This indicates that the DDU-100 AED is actively
analyzing the patient’s ECG signal. The AED will continue analyzing until it has
determined whether a rhythm is shockable or non-shockable or analyzing is
interrupted for some reason. The “analyzing” LED will flash green during this period.
“Do not touch the patient” – This indicates that the DDU-100 AED is trying to
analyze the patient’s heart rhythm and that the operator should not touch the patient.
This message will be spoken at the beginning of the analysis period and also if
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motion or interference has been detected. The “do not touch patient” LED will flash
red during this message.
“Analyzing interrupted” – This indicates that the DDU-100 AED has determined
that accurate ECG analysis is not possible and has ceased analyzing. The operator is
prompted to resolve the problem – see “Follow DDU-100 AED Prompts” section.
Once the problem is resolved, the unit will enter analysis mode again. The
“analyzing” LED will not be illuminated during this message.
“No shock advised” – This indicates that the DDU-100 AED has determined
that a shock is not required. The unit will not charge and the SHOCK button will
not be enabled. The user will be prompted to begin CPR, if needed, for a period
of two minutes.
“Shock advised” – This indicates that the DDU-100 AED has determined that
a shock is recommended and the unit will begin charging in anticipation of a
defibrillation shock. Analysis will continue and the “analyzing” LED will continue
to flash green.
4.6 Delivering the Shock
If the DDU-100 AED ECG analysis algorithm has determined that a shock is
required, the unit will automatically charge in preparation for shock delivery.
While the AED charges, the unit will continue to analyze the patient’s heart
rhythm. If the unit detects that the heart rhythm has changed to one that does
not require a shock, the unit will abort the charging process and will prompt the
user to begin CPR, if needed, for a period of two minutes. Also while charging,
the AED will continue to monitor the pad connections and will abort charging if it
detects any pad problems. It will also continue to monitor for excessive motion
or interference and will abort charging if those conditions are detected. The user
can abort at any time by pushing the ON/OFF button to turn the unit off.
Shock related voice prompts:
“Charging” – This indicates that the DDU-100 AED has determined that a shock
is recommended and is charging the unit in anticipation of a defibrillation shock.
Analysis will continue during this phase and the “analyzing” LED will continue to
flash green. A tone will sound to indicate charging progress. If the unit detects a
rhythm change to a non-shockable one, charging will abort and the user will be
prompted to begin CPR, if needed, for a period of two minutes.
“Stand Clear” – This indicates that the DDU-100 AED is charging and that the
operator and others should stand clear of the patient. Analysis will continue
during this phase and the “analyzing” LED will continue to flash green. A tone
will sound to indicate charging progress. If the unit detects a rhythm change to
a non-shockable one, charging will abort and the user will be prompted to begin
CPR, if needed, for a period of two minutes.
“Press flashing shock button” – This indicates that the DDU-100 AED has
fully charged, that the heart rhythm analysis algorithm still indicates a shock is
recommended, and the unit is ready to deliver a shock. The operator should
press the SHOCK button to deliver the shock. The “Shock” button will flash
during this phase.
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• Off: No Shock indicated. Button is disabled,
pressing the button will do nothing.
SHOCK
• Flashing: Shock is recommended. The
device is charged and ready to shock.
Button is enabled. Press the button to
administer shock.
“Shock ‘x’ delivered” – This indicates that the DDU-100 AED has delivered the
shock. The ‘x’ indicates the number of shocks that have been delivered since
the unit was turned on (note: if the unit delivers more than 15 shocks during one
on period, the count will get reset to “one” on the sixteenth shock). After each
shock, the AED will enter Post-Shock CPR mode (see below).
“Shock cancelled” – This indicates that the DDU-100 AED has aborted shock
mode and internally discharged. If while waiting for the shock button to be
pressed, the unit detects a rhythm change to a non-shockable rhythm, the unit
will cancel the shock. Also, if the shock button is not pressed within 30 seconds
of the initial “press flashing shock button” prompt, the unit will automatically
cancel the shock.
Note: The DDU-100 AED will not automatically deliver a shock – the user must
press the SHOCK button.
Note: At any time during the charging process or after the AED has been
charged, the operator may disarm the unit by pressing the ON/OFF button.
4.7 No Shock Required
If the DDU-100 AED ECG analysis algorithm has determined that a shock is not
required, it will not charge the unit and the SHOCK button will not be enabled.
The operator will be prompted to begin CPR, if needed, for a period of two
minutes. The unit will not be monitoring the patient’s ECG rhythm during this
two minute CPR period.
During this two-minute period, the AED will not advise the user to “stop motion”
even if motion is present. During the two-minute period, the AED will announce
time remaining in 15-second intervals. At the end of the two-minute period, the
unit will enter normal Analyzing mode.
No Shock Required Voice Prompts:
“It is safe to touch the patient” - This indicates that the DDU-100 AED analysis
algorithm has determined that no shock is required. The unit will not charge and
the SHOCK button will not be enabled. The user will be prompted to begin CPR,
if needed, for a period of two minutes. The “analyzing” LED will remain off to
indicate that background rhythm monitoring has been suspended.
“Check airway”, ”Check breathing” – This indicates that the user should check
the condition of the patient in order to determine if it is appropriate to perform
CPR.
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“If needed, begin CPR” – This indicates that the user should begin CPR, if
needed, for two minutes. The unit will not be monitoring the patient’s ECG
rhythm during this two minute CPR period. The “analyzing” LED will remain off
to indicate that background rhythm monitoring has been suspended.
“Continue for ‘x’ Seconds” or “Continue for 1 Minute ‘x’ Seconds” This
indicates that the user should continue CPR, if needed, for ‘x’ more seconds or,
for 1 minute and ‘x’ more seconds, respectively. The unit will not be monitoring
the patient’s ECG rhythm during this two minute CPR period. The “analyzing”
LED will remain off to indicate that background rhythm monitoring has been
suspended.
“Continue” – This indicates that the user should continue CPR, if needed.
This phrase is spoken between the “continue for ‘x’ seconds” or “continue
for 1 minute ‘x’ seconds” prompts to let the operator know that the unit is still
operating normally. The unit will not be monitoring the patient’s ECG rhythm
during this two minute CPR period. The “analyzing” LED will remain off to
indicate that background rhythm monitoring has been suspended.
“Continue for 5, 4, 3, 2, 1”, “Stop CPR” – This indicates that the user should
finish performing CPR. This phrase is spoken during the last several seconds of
the two-minute CPR period to let the operator know that the unit is still operating
normally and that the two-minute period is ending.
“Stop now”, “Do not touch the patient” – This indicates that the two-minute
CPR period has ended and the user should stop CPR. The unit will enter Analyze
mode and the “analyzing” LED will flash.
4.8 Post-Shock CPR
If the DDU-100 AED has delivered a shock, the unit will require a mandatory
two-minute CPR period. No patient ECG rhythm monitoring will be done during
this period. Once the two-minute period is complete, the AED will continue in
Analyzing mode.
Post-Shock CPR Voice Prompts:
“It is safe to touch the patient” - This indicates that it is safe for the user to touch the
patient. The unit will not be monitoring the patient’s ECG rhythm during this required
two minute CPR period. The “do not touch patient” LED will be off to indicate that it
is safe to touch the patient.
“Begin CPR now” – This indicates that the user should perform CPR for two minutes.
The unit will not be monitoring the patient’s ECG rhythm during this required two
minute CPR period. The “analyzing” LED will remain off to indicate that background
rhythm monitoring has been suspended.
“Continue for ‘x’ Seconds” or “Continue for 1 Minute ‘x’ Seconds” This indicates
that the user should continue performing CPR for ‘x’ more seconds or, for 1 minute
and ‘x’ more seconds, respectively. The unit will not be monitoring the patient’s ECG
rhythm during this required two minute CPR period. The “analyzing” LED will remain
off to indicate that background rhythm monitoring has been suspended.
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“Continue” – This indicates that the user should continue performing CPR. This
phrase is spoken between the “continue for ‘x’ seconds” or “continue for 1 minute
‘x’ seconds” prompts to let the user know that the unit is still operating normally. The
unit will not be monitoring the patient’s ECG rhythm during this required two minute
CPR period. The “analyzing” LED will remain off to indicate that background rhythm
monitoring has been suspended.
“Continue for 5, 4, 3, 2, 1”, “Stop CPR” – This indicates that the user should finish
performing CPR. This phrase is spoken during the last several seconds of the required
two-minute CPR period to let the user know that the unit is still operating normally and
the two-minute period is ending.
“Stop now”, “Do not touch the patient” – This indicates that the mandatory twominute CPR period has ended and the user should stop CPR. The unit will enter
Analyze mode and the “analyzing” LED will flash.
4.9 Post Use Procedures
After the DDU-100 AED has been used on a patient, the unit should be cleaned
following procedures in the “Cleaning” section and prepared for the next use.
The following steps should be performed:
•
•
•
•
Remove battery pack.
Remove DDC if installed. Replace with a new DDC.
Reinsert battery pack. Check that the battery insertion self-test passes.
Connect a new pad package (check to make sure the package is not
expired).
• Hold ON/OFF button down for at least five seconds to initiate a manually
initiated Self-Test. Unit will report status of self-test and shut off.
• Check to make sure that the Active Status Indicator is flashing green.
4.10 Operational Environment
The Defibtech AED is designed to operate in a wide range of environmental
conditions. To ensure the reliability and safety of the AED in a given
environment, refer to the “Environmental” section for a detailed list of approved
environmental conditions.
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10 Contacts
Defibtech, L.L.C.
741 Boston Post Road
Guilford, CT 06437
Tel.:
Fax :
(866) 333-4241 (Toll-free within North America)
(203) 453-4507
(203) 453-6657
Emails: [email protected]
(Sales)
[email protected] (Medical Device Reporting)
[email protected] (Service and Repair)
European Authorized Representative:
Emergo Europe
Molenstraat 15
2513 BH The Hague
The Netherlands
Tel.: +31 70 345 8570
Fax:
+31 70 346 7299
0197
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Patents pending.
This product and its accessories are manufactured and sold under one or more of
the following United States patents: D514,951; 6,955,864; D499,183; D498,848;
6,577,102.
This product and its accessories are manufactured and sold under license to at
least one or more of the following United States patents: 5,591,213; 5,593,427;
5,601,612; 5,607,454; 5,611,815; 5,617,853; 5,620,470; 5,662,690; 5,735,879;
5,749,904; 5,749,905; 5,776,166; 5,800,460; 5,803,927; 5,836,978; 5,836,993;
5,879,374; 6,016,059; 6,047,212; 6,075,369; 6,438,415; 6,441,582.
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